ML20136E278
Text
~
"p# 4 UNITED STATES y '), NUCLEAR REGULATORY COMMISSION
, o L WASHINGTON, D. C. 20555
'i
%g...../ SEP 2 1982 MEMORANDUM FOR: Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety FROM: Carlyle Michelson, Director Office for Analysis and Evaluation of Operational Data
SUBJECT:
PROPOSED REVISION OF 10 CFR PART 35 AE0D's comments on the subject paper are as follows:
- 1. We recommend that the Commission Paper and Statement of Consideration describe the applicability of the proposed rulemaking to medical licensees other than group and teletherapy licensees.
- 2. We have following comments on specific sections of the proposed 10 CFR Part 35 as follows:
- a. " 5 35.70 Surveys for contamination and ambient radiation exposure rate.
(a) Each licensee shall survey with a low range survey meter at the end of each day of use all areas where radiopharma-ceuticals are routinely prepared for use or administered.
(b) Each licensee shall survey with a low range survey meter at least once each week all areas where radiopharmaceu-ticals or radiopharmaceutical waste is stored."
COMMENT: As is presently the case, it would appear that a requirement to perform wipe surveys and contamination limits should be part of the survey requirements.
- b. " s 35.205 Control of aerosols and gases An individual who adminsters radioactive aerosols or gases shall do so with a system which will prevent the unintended dispersal .of the byproduct material and is either directly vented to the atmosphere through an air exhaust or provides for collection and decay or disposal of the aerosols or gas in a shielded container."
6zG9z$$$3$ d
~ sg-
COMMENT: 6 35.205 is a general description of NRC requirements for the safe use of aerosols and gases. In the past in the material license review process, generalized statements from applicants have not been accepted by NRC. It appears to be inconsistent to use the same type of statement to convey an NRC requirement to an applicant or 1,1censee. .j
.4 ,
'v- t gn si
- c. " g 35.304 Safety instruction r (a) The authorized user shall provide oral and written radia-tion safety instructions for all personnel caring for the patient undergoing radiopharmaceutical therapy. To satisfy this requirement, the instructions must describe procedures for:
(1) Patient control; (2) Visitor control; (3) Contamination control; and (4) Waste control.
(b) The licensee shall keep for two years a list of individuals receiving instructions required by paragraph (a) of this section, a description of the instructions, the date of instruction, and the name of the individual who gave the instructions."
3 35.405 Safety instruction (a) The authorized user shall provide written radiation safety instructions to all individuals caring for the patient undergoing brachtherapy. To satisfy this requirement, the instructions must describe procedures for:
(1) Patient control; and (2) Visitor control.
(b) The licensee shall keep for two years a list of individuals receiving instructions maintaing records to show compliance with the required by paragraph (a) of this section, a des-cription of the instructions, the date of instruction, and the name of the individual who gave the instruction."
COMMENT: Doesn't the way g 35.304 and 305 are written inhibit NRC inspectors from citing licensees for deviations from their own procedures since there is no requirement that the (p N:G P
po.. .
procedures be followed. In addition, should not Part ,73
,M 35 require the licensee to audit compliance with its //hl.; A4
.own procedure. jjo e &
Carlyle Michelson, Director Office for Analysis and Evaluation of Operational Data 1
1
. , . ,